What is your definition of regenerative medicine?
Regenerative medicine involves using cells, rather than molecules or chemical substances, to regenerate or replace functions or parts of the body that are missing or not working. It is a field that encompasses the use of cells and tissues to create or fix tissue, marking a significant advancement in medical care. This approach is distinct from the use of traditional devices and pharmaceuticals in care and treatment, establishing a new frontier in patient care.
Could you introduce us to your therapeutic product called the HAV?
Our therapeutic product, the Human Acellular Vessel (HAV), uses human cells to create replacement tissues. This technology leverages a bioreactor process that mimics the human body's environment, enabling us to grow engineered arteries that can treat various vascular diseases. The versatility of our platform allows for the creation of tissues in different shapes and sizes, tailored to a wide range of medical needs. Importantly, the HAV is infection-resistant, universally implantable, and can be produced at commercial scale, meaning we could leverage this process to easily create enough replacement blood vessels to help save the lives and limbs of tens of thousands of patients in the longer term.
How do you intend to bring the HAV to market, and have you used it to treat patients already?
The process of bringing the HAV to market has so far involved extensive testing in animals and patients, with over 550 patients treated in clinical trials for a range of diseases over the past ten years. Our goal is to gain FDA approval for an indication in vascular injury supported by the data we have shared from these trials, aiming for market entry within a year.
Why did you choose to focus on larger tissues initially with HAV?
The focus on larger tissues was driven by their clinical utility. Our engineering platform allows us to make tissues of all different shapes and sizes, so our decision to concentrate mainly on larger tissues was not a response to challenges associated with engineering different tissue sizes but instead a result of determining what would be most beneficial for medical procedures, including dialysis access and treating trauma. The size of the tissue we engineer, 40 millimeters long and six millimeters in diameter, is really ‘one-size-fits-most’ – applicable in treatment for multiple injuries and diseases.
Can you tell us about your work with the HAV in Ukraine?
In Ukraine, we have seen encouraging results from the use of the HAV in frontline hospitals.
Shortly after the Russian invasion of Ukraine, we realized the potential for the HAV to help treat soldiers and those injured in the war. We worked with both the FDA and the Ukrainian Ministry of Health to coordinate a shipment into the country, and trained Ukrainian surgeons via videoconference on their implantation. The HAV was ultimately used to treat 19 Ukrainian patients with wounds from shrapnel, landmines, and gunfire. The positive outcomes, including restored blood flow without amputations or infections, highlight the HAV's significant impact in emergency and critical care situations.
How do you manage the availability of the HAV for emergency use? What is its on-shelf longevity?
The HAV is designed for immediate availability in emergencies, with a shelf life of 18 months. We grow the vessels in bioreactors, then remove the cells to eliminate immunogenicity, allowing for universal implantation. This ensures the HAV can be stored and readily used as needed, providing a practical solution for urgent vascular repairs.
Is growing these tissues expensive?
While growing human arteries is more expensive than producing synthetic grafts, the benefits significantly outweigh the costs, especially when compared to the complications associated with synthetic materials. The anticipated price of the HAV, while higher than synthetic options, is deemed reasonable considering its medical value and the efficiency of our manufacturing process. This makes the HAV a viable and transformative option in vascular and regenerative medicine.
Have you observed any cases of rejection with the HAV similar to organ rejections?
We have not encountered a single case of rejection in the 550 patients treated over more than a decade. This is significant because it underscores the biocompatibility and safety of our HAV product. Particularly noteworthy is the durability of these vessels; some patients have been using their HAVs for as long as ten years without issues. We attribute this longevity to the HAV becoming a living artery over time, as stem cells from the patient's body migrate into the vessel, maintaining its structure and function.
How can your technology address type 1 diabetes?
Our success in engineering blood vessels that integrate well with the human body and support arterial blood flow opens the door to broader applications in regenerative medicine, including treating type 1 diabetes.
The challenge in organ engineering has often been delivering sufficient blood flow to sustain clusters of therapeutic cells. By combining our blood vessels with cell clusters, such as pancreatic islets that produce insulin, we can potentially create a biovascular pancreas. This approach has shown promise in preclinical studies, and we are moving towards clinical trials, aiming to deliver a revolutionary treatment for patients with type 1 diabetes.
Why did you decide to take Humacyte public in 2020? Relatedly, how do you assess the investment market for biotech companies today?
Humacyte went public in 2021 to secure the necessary funding for Phase 3 trials, commercial manufacturing, and product launch, which was beyond the scope of private financing. This move was timely, capitalizing on a buoyant biotech market, and has provided us with a substantial runway to advance our projects.
Despite the cyclical nature of biotech financing, with recent years being challenging, we are optimistic about the future. Our strong cash position and anticipated market entry position us well for the coming years, regardless of broader market uncertainties.
Looking ahead, where do you see Humacyte in three to five years?
In the next three to five years, we aim to have additional indications approved for our HAV in both the U.S. and internationally, addressing needs in dialysis and peripheral artery disease treatment. We also expect to be in early-stage clinical trials for our biovascular pancreas to treat type 1 diabetes and for using the HAV in coronary artery bypass surgery (CABG).
While vascular trauma is our focus right now, the potential of the HAV to transform some of our trickiest medical challenges is limitless, and we have a lot of exciting work that is currently taking place in those areas.
